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Bending Adolescent Depression Trajectories Through Personalized Prevention

2 de março de 2021 atualizado por: Children's Hospital of Philadelphia
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.

Visão geral do estudo

Descrição detalhada

Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence. A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents. These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions. The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.

Tipo de estudo

Intervencional

Inscrição (Real)

205

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Colorado
      • Denver, Colorado, Estados Unidos, 80208
        • University of Denver
    • Illinois
      • Champaign, Illinois, Estados Unidos, 61820
        • University of Illinois Urbana Champaign
    • New Jersey
      • Piscataway, New Jersey, Estados Unidos, 08854
        • Rutgers University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19146
        • Children's Hospital of Philadelphia

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 17 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Currently in the 6th to 11th grades
  • Adolescent and parent must be English-speaking
  • Parental consent and adolescent consent

Exclusion Criteria:

  • Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
  • Suicide attempt in the past week or significant suicidal ideation in the past week
  • Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Interpersonal Psychotherapy- Adolescent Skills Training
A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.
Outros nomes:
  • IPT-AST
  • Teen Talk
Experimental: Coping with Stress
A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.
Outros nomes:
  • CWS

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Presence of a Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: Post intervention (approximately 3 months post baseline)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Post intervention (approximately 3 months post baseline)
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 6-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
6-months post-intervention
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 12-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
12-months post-intervention
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 18-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
18-months post-intervention
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 24-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
24-months post-intervention
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 30-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
30-months post-intervention
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 36-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
36-months post-intervention
Children's Depression Inventory (CDI)
Prazo: Post intervention (approximately 3 months after baseline)
Self-reported depression scores
Post intervention (approximately 3 months after baseline)
Children's Depression Inventory (CDI)
Prazo: 6-months post-intervention
Self-reported depression scores
6-months post-intervention
Children's Depression Inventory (CDI)
Prazo: 12-months post-intervention
Self-reported depression scores
12-months post-intervention
Children's Depression Inventory (CDI)
Prazo: 18-months post-intervention
Self-reported depression scores
18-months post-intervention
Children's Depression Inventory (CDI)
Prazo: 24-months post-intervention
Self-reported depression scores
24-months post-intervention
Children's Depression Inventory (CDI)
Prazo: 30-months post-intervention
Self-reported depression scores
30-months post-intervention
Children's Depression Inventory (CDI)
Prazo: 36-months post-intervention
Self-reported depression scores
36-months post-intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Children's Global Assessment Scale (CGAS)
Prazo: Post Intervention (approximately 3 months following baseline)
Assesses global functioning
Post Intervention (approximately 3 months following baseline)
Children's Global Assessment Scale (CGAS)
Prazo: 6-months followup
Assesses global functioning
6-months followup
Children's Global Assessment Scale (CGAS)
Prazo: 12-months followup
Assesses global functioning
12-months followup
Children's Global Assessment Scale (CGAS)
Prazo: 18-months followup
Assesses global functioning
18-months followup
Children's Global Assessment Scale (CGAS)
Prazo: 24-months followup
Assesses global functioning
24-months followup
Children's Global Assessment Scale (CGAS)
Prazo: 30-months followup
Assesses global functioning
30-months followup
Children's Global Assessment Scale (CGAS)
Prazo: 36-months followup
Assesses global functioning
36-months followup

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Jami F Young, Ph.D., Children's Hospital of Philadelphia

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2013

Conclusão Primária (Real)

1 de agosto de 2019

Conclusão do estudo (Real)

1 de agosto de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

18 de setembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de setembro de 2013

Primeira postagem (Estimativa)

23 de setembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de março de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de março de 2021

Última verificação

1 de março de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 17-013831
  • R01MH077178 (Concessão/Contrato do NIH dos EUA)

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